Principal Quality Engineer currently based at Illumina, Inc.Developed risk-based methodology used to realize a 30% reduction in time associated with the review of Research Use Only (RUO) batch records. RUO batch records account for approximately 70% of all batch records reviewed, and implementation of the risk-based approach shifted QA-review focus to more value-added reviews of production critical and final Dx product release DHRs. Owner of a Corrective Action and Preventive Action (CAPA) aimed at reducing product and compliance risks related to the loss of paper batch records. Worked with a cross-functional team to perform root cause analysis, and subsequent implementation of corrective actions. Performed a gap analysis study in all manufacturing areas to identify and execute process improvements required to prevent loss, damage, and deterioration of product records. The investigation, approval, and implementation phases of the CAPA were completed within the key performance indicator requirements of 180 days.

Worked with a team of scientists, engineers, and quality professionals on developing, characterizing, verifying, and validating DNAe’s new system which enables rapid, near-patient, real-time diagnostics for suspected blood stream infections. Primary responsibilities include: Validation Team Lead responsible for establishing validation project timelines incorporating all required DNA-Free manufacturing processes and reagents. - Established a justifiable definition for DNA-Free that could be used to support the end product clinical sensitivity and specificity requirements. - Extensive research and testing led to an analytical definition of DNA-Free as ≥ 6 log DNA reduction after exposure to the applicable sterilization process. - Analyzed validation test data to determine whether systems or processes have met validation criteria and authored detailed validation reports based on test results. - Identified and resolved protocol deviations observed during the validation process. Assessed the deviation impact upon the validation which included root cause, corrective action, and justification of the decision to either accept or reject the data. - Ethylene oxide, dry heat, UV-C irradiation, and silica oxide columns were validated as effective sterilization and DNA degradation methods. - Used real-time qPCR and FastStart SYBR Green Master for analyzing the effectivity of DNA degradation and sterilization methods. - Developed and validated complex MS Excel spreadsheets. Spreadsheet validations ensured that non-standard formulas, calculations, and data inputs, reliably performed as intended and delivered the necessary outputs to properly disposition other validation studies. - Generated IQ/OQ protocols and reports for various laboratory equipment ensuring the written acquisition specifications were met.

Sr. Quality Engineer for the world's first and only FDA, Health Canada, and CE approved Total Artificial Heart (TAH). The TAH is a PMA approved Class 3 life-sustaining device that is pumped through the use of one of three pneumatic driver systems, which are also manufactured at SynCardia Systems. Lead facilitator of complex failure investigations on all TAH components, pneumatic drivers, and driver accessories, to determine if the failure mode caused any adverse patient impact. Coordinated and collaborated on all failure investigations from the authoring process through to final approval. Timely closure of failure investigations was required to ensure driver availability to hospitals and patients. Provided development and sustaining quality engineering support for all pneumatic driver systems, including troubleshooting of device malfunctions, and documentation requirements. Developed new suppliers, verified and validated design changes, performed IQ, OQ, PQ, and collaborated and final approved all documentation and product updates. Authored Health and Hazard Evaluations (HHEs), required by the FDA, when an issue was identified with distributed product that may have resulted in field service actions. Through extensive product analysis and risk management, product recalls were avoided. HHEs were used as part of the corrective and preventative action process to implement additional risk measures and new product tracking processes

Sr. Quality Engineer for a $40M commercial aerospace company with product lines including emergency batteries, mainship batteries, inverters/converters, battery chargers, security systems, cameras, wireless emergency lighting, and all incoming and final quality inspection.- Implemented a compliant approved supplier system in response to a major CAR from DNV, Securaplane’s third party auditors. System was semi-automated with controls in place to ensure only suppliers that met the required quality standards were used for part purchasing. The approved supplier process was re-audited, and there were no findings, and the corrective action request was deemed effective and closed. - Tasked as part of a policy deployment team to reduce parts per million defects by 50% for two consecutive years. Designed and implemented a visual management process where defects were evaluated by pareto analysis. Used tools such as “5-Whys” to determine root cause and corrective action (RCCA). RCCA was performed only on clear quality issues. - Resolved many issues through error proofing, testing, and additional inspection.- Reduced PPMs from 46,000 in 2010 to 19,786 in 2011; a more than 50% reduction.- Directed Securaplane’s transition from AS9100B to AS9100C.- Documented by gap analysis Securaplane’s deficiencies from AS9100B to AS9100C and then implemented action plans to resolve the deficiencies. - DNV audited Securaplane against the AS9100C standard for 3 days with no findings. The auditors stated that this was the best planned and organized audit performed in the last 2 years of this transition and completing an audit with no findings is very rare. - Achieved AS9100C certification 4 months ahead of schedule.

Sr. Quality Engineer/Risk Manager for development of cancer diagnostic molecular probes and detection technology and hardware. Quality core team member responsible for ensuring compliance to the Ventana’s quality system. - Authored all project management documentation, including risk plans, dFMEAs, pFMEAs, HAMs, sFMEAs, aFMEAs, residual risk reports, design and development plans, and stability protocols. - Collaborated on and approved development documentation and protocols that were submitted to the FDA for 510K/PMA approval. Required extensive knowledge of the product development process, encompassing design verification, validation and process validation. Launched several new molecular probe and detection kit products used in the diagnosis of breast and lung cancer, with significant sales and growth opportunities in the millions, worldwide.

Sr. Quality Engineer and Multi-Missile Factory Integrated Product Team Leader for Joint Stand-Off Weapon (JSOW), Process Composite Factory, Ultra Precision Fabrication shop, and injection molded products. - Responsible for product quality, reliability and assuring products met contract specifications. - Chaired the JSOW, Process Composite, and Ultra Precision Fabrication shop monthly corrective action boards. Tracked and analyzed product defects using pareto charts and conducted root cause and corrective action analysis. - Managed the Material Review Board, and was quality representative for change control. Conducted monthly product and process verification audits and reported results, with suggested solutions, monthly, to upper management. - Implemented quality initiatives which lead to the government designation of the Composites and Fabrication factories as world class facilities. - Lead of the JSOW team that helped Raytheon win the University of Utah’s Shingo Award for excellence in Lean Manufacturing. - Facilitated JSOW’s win of the Raytheon’s Operations Program of the Year Award for two years in a row. Gained the program exceptional customer satisfaction with the Navy and Air Force. Decreased weapon costs by approximately 100K/unit which resulted in further product contracts as well as joint cost avoidance and cost reduction activities.

- Performed enzyme linked immunoassays for several infectious disease diagnostic products and reported quality control test results. Increased productivity, generated higher quality products, minimized cycle time and improved first-pass acceptance rates.- Supervised the TestPack Chlamydia manufacturing line. Ensured quality products on-time, maintained product availability, reduced compliance risks, increased team efficiency and simplified whole panel manufacturing and testing processes.- Originated search for alternate supplier of polystyrene immunoassay beads manufactured by injection molding for several diagnostic products. New bead component was qualified for 35% of Abbott’s bead assays, reducing overhead, increasing profit margin and first-pass acceptance rates from 40% to over 90%.- Performed supplier failure analysis and audits, assured supplier compliance, conducted experiments, generated and interpreted data, wrote and approved document changes.